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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK 4580 FMS DUO+ PUMP/SHAVER COMBO FMS PUMPS

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DEPUY MITEK 4580 FMS DUO+ PUMP/SHAVER COMBO FMS PUMPS Back to Search Results
Catalog Number 284580
Device Problem Pressure Problem (3012)
Patient Problem No Information (3190)
Event Date 10/04/2016
Event Type  Injury  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
 
Event Description
Biomed tech calling in complaint patient harmed looking to have equipment evaluated. When using pump something happened while knee surgery and too much pressure was placed in joint. Patient has lawyers and a lawsuit pending. Biomed tech does not have clear details on surgery claims surgery aborted. Equipment hospital owned. On 11/14: the issue may be with the tube set and not pump. Customer has sent replacement pump back from this complaint.
 
Manufacturer Narrative
The issue was with the tube set and not pump customer has sent replacement pump back from this complaint and will not be returning product on complaint. The complaint device is not being returned, therefore unavailable for a physical evaluation. The reported condition could not be confirmed. Further, a review into the depuy synthes mitek complaints system revealed no other complaint for this serial number that was released to distribution. At this point in time, no corrective action is required and no further action is warranted. However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field. The tubeset has been reported under medwatch: 1221934-2016-10453.
 
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Brand Name4580 FMS DUO+ PUMP/SHAVER COMBO
Type of DeviceFMS PUMPS
Manufacturer (Section D)
DEPUY MITEK
325 paramount drive
raynham MA 02767
Manufacturer Contact
jennifer lawrence
325 paramount drive
raynham, MA 02767
5089776860
MDR Report Key6123611
MDR Text Key60745316
Report Number1221934-2016-10503
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number284580
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Report to Manufacturer10/27/2016
Date Manufacturer Received11/14/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 11/23/2016 Patient Sequence Number: 1
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